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 Blockbuster drugs such as GlaxoSmithKline's hepatitis drug Viread,
AstraZeneca's heart drug Brilinta and Sanofi's chronic kidney
disease drug Renvela were up for inclusion over the coming weeks,
industry executives said, virtually guaranteeing an uplift in sales.
Industry insiders and analysts said oncology drugs were also likely
to be added to national and regional lists. Poor access to targeted
cancer drugs is a hot-button issue in China, where patients often
take on crippling debts or turn to grey markets to get treatment.
Changes to the National Reimbursement Drug List (NRDL), which
determines which drugs are part-sponsored by the government, will be
a welcome shot in the arm for global drug companies, most of whom
saw sales growth slow or contract last year in the world's number
two pharmaceutical market.
"It's pretty much the most important list to get on. Being added can
really mean sales of a drug skyrocket," said a Shanghai-based
executive at a large British drugmaker.
Inclusion on the NRDL means a drug is accessible through state
insurance schemes, making it affordable to mass market consumers.
Any new drug approved for sale since the last update of the list in
2009 was until now largely paid for out-of-pocket by patients.
Most additions to the list, currently just over 2,000 strong, will
be traditional Chinese medicines, but roughly 130 are expected to be
modern drugs.
"Inclusion on the list reduces the burden of self-pay, as drugs on
the list can be reimbursed up to 80 percent depending on local
implementation," said Jordan Liu, Shanghai-based associate principal
at healthcare research and services company QuintilesIMS.
An executive at another global drugmaker said the list was expected
to be published in the "first few months of 2017", though some
analysts said it could be as early as the Lunar New Year holiday
that starts later this week. There could be a further negotiation
period for high-priced drugs.
HORSE TRADING
Drug companies have spent months lobbying government advisory
committees to get their drugs on the NRDL, executives said. The
experts on these committees vote for which drugs to include.
The Ministry of Human Resources and Social Security (MOHRSS) and the
finance ministry are then involved in a final decision, based on
factors including clinical need and cost - though several industry
insiders said the process was opaque and the measures used to judge
criteria such as clinical effectiveness were unclear.
Even once on the NRDL, drug makers negotiate pricing and access for
their drug on separate provincial lists.
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Access to the country's main lists - which includes the NRDL along
with the Essential Drug List (EDL) for the most critical drugs -
also comes with strings attached.
Drugmakers often have to cut prices steeply to be included, helping
China's drive to lower drug prices and rein in a healthcare bill
McKinsey estimates hitting $1 trillion by 2020.
"To gain market access, it's crucial for companies to be able to
show the value of their therapies in terms of improved outcomes and
optimized overall cost-of-care," added QuintilesIMS's Liu.
GlaxoSmithKline agreed to a 67 percent cut to the price of hepatitis
B drug Viread in May, eyeing in return a major volume boost. GSK
declined to comment for this story.
RARE OPENING
Drugmakers say the update will improve access to medicines for
Chinese patients, who often have to wait years after drugs are
approved in other countries or pay for the latest drugs
out-of-pocket.
"AstraZeneca is pleased that the China government has opened a
review of the national drug reimbursement list, which will benefit
patients in China in terms of both access and affordability of
innovative and high quality drugs," said Laurence Huang, vice
president of government affairs for Asia.
Analysts said local firms could benefit too. CSPC Pharmaceutical
Group Co Ltd, Sino Biopharmaceutical Ltd, 3SBio Inc have drugs that
have a good chance to get on to the NRDL.
Dublin-based drugmaker Shire, which specializes in rare diseases,
told Reuters in November that it hoped to get its haemophilia
treatment on the main section of the NRDL as part of a drive to
double its Asian sales by 2020.
Patients currently have only limited access to the drugs.
"This is a rare opening of the NRDL. It is a window of opportunity,"
said Peter Fang, Shire's head of Asia Pacific.
(Reporting by Adam Jourdan; Editing by Clara Ferreira Marques and
Alex Richardson)
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